2. Global Burden of MDR Tuberculosis
14 million TB patients worldwide
About 0,5 million cases of MDR TB
First 5 countries with MDR-TB: India
(131 000), China (112 000), the
Russian Federation (43 000),
South Africa (16 000) and
Bangladesh (15 000).
25% of global MDR TB treatment
expenses are spent in Russia
Only 22% of MDR TB patients in
Russia receive appropriate
treatment
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3. Unmet medical needs
The existing TB-treatment regimens are based on the drugs
developed in the 40’s, 50's, early 60's
The existing drugs have poor or no effect on MBT (drug resistance)
The growing incidence of MDR TB worldwide
A number of cases of total drug resistance
The treatment cost of MDR-TB patients is in average 10 times
higher than drug-sensitive
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4. SQ109
Unique mechanism of action
Targets MmpL3, a membrane transporter of Tregalose Monomycolate
involved in Mycolic Acid donation to the MBT cell wall
Prevents drug efflux of other companion drugs, improving their kill
capacity
1,2-diamine related to ethambutol
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5. SQ109
Key advantages
Synergistically improves other drug activity:
8-fold for Rifampicin, Rifapentine (Sanofi), Rifabutin (Pfizer)
4 to 8-fold for TMC207 (J&J Tibotec)
2 to 4-fold for PNU100480 (Pfizer)
8-fold for Clofazimine (generic)
No natural resistance and low resistance generation rate:
≥1000-fold better than other TB drugs:
Resistance generation, 1 in 2x1012 (2 trillion) bacteria
Effective against latent TB infection
No expected drug-drug interaction
2D6 and 2C19 Cytochrome P450
no interaction with 3A4
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6. SQ109
Combination therapy – preclinical data
Residual CFU M. tuberculosis after 6 wk treatment
INH+RIF+ SQ109 +PZA INH+RIF+EMB+PZA
(standard of care)
Undiluted lung homogenate samples plated on 7H10 agar
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7. SQ109
Development status and strategy
Proved preclinical safety and efficacy (in vitro and in vivo)
Proved safety in series of early stage clinical trials
80 healthy subjects in 5 phase 1 CT
90 TB subjects in phase 2A EBA study
Ongoing long-term preclinical testing (in vivo)
Ongoing pivotal clinical trial in Russia for MDR TB
treatment
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8. Intellectual Property
Exclusive Licensing
License object: Patent EA № 013965. Expiry: 19.05.2023.
Title: Anti tubercular drug: compositions and methods
License territory: RF, Ukraine, Belarus, Kazakhstan, Moldova, Kirgizia,
Tajikistan, Turkmenistan, Azerbaijan, Armenia
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9. Team
Oksana Markova — Chief Executive Officer
Graduated from Smolensk Medical Academy, was engaged in
research activities. Since 1997, worked for InnoFarm, went all
the way from the centers monitor to clinical project manager.
Knows all the aspects of the organization of clinical trials and
registration of the finished drug products. Since 2010, as part of
Maxwell Biotech Group organized the evaluation of the incoming
projects at clinical stage, participated in the planning of clinical
studies and the preparation of investment decisions. Since 2011
— CEO of Infectex
Sergey Borisov — Scientific Advisor
Doctor of Medical Science, Professor of TB at Russian Medical
Academy of Postgraduate Education, Deputy Director for science
and clinical work at Moscow Research Center for TB control of
the Moscow Department of Health.
Main scientific work (300 papers in national and international
journals) is devoted to the diagnosis, treatment and follow-up of
patients with tuberculosis and other respiratory diseases.
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10. Thank you for your attention
Infectex Ltd
markova@infectex.ru
+7 (495) 411-69-92
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